HDCT and Stem Cell Transplantation for Mantle Cell and Relapsed Low Grade Non-hodgkin's Lymphoma
Primary Purpose
Low Grade Lymphoma
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
stem cell source
Sponsored by
About this trial
This is an interventional treatment trial for Low Grade Lymphoma focused on measuring autologous and allogeneic stem cell transplantation, low grade lymphoma, mantle cell
Eligibility Criteria
Inclusion Criteria: indolent histology lymphomas after relapse 1 or 2 LVEF > 50% Creatinine < 150 umol/L bilirubin < 30 umol/L wbc >3.5X10^9/L platelets >100X10^9/L other medical condition as controlled Exclusion Criteria: pregnant lactating HIV positive CNS involvement by lymphoma other malignancy
Sites / Locations
- Tom Baker Cancer Centre
Outcomes
Primary Outcome Measures
feasibility
mortality
overall survival
event free survival
Secondary Outcome Measures
Full Information
NCT ID
NCT00144092
First Posted
September 1, 2005
Last Updated
November 18, 2011
Sponsor
Alberta Health services
1. Study Identification
Unique Protocol Identification Number
NCT00144092
Brief Title
HDCT and Stem Cell Transplantation for Mantle Cell and Relapsed Low Grade Non-hodgkin's Lymphoma
Official Title
High Dose Chemotherapy and Autologous or Allogeneic Blood Stem Cell Transplantation for Mantle Cell and Relapsed Low Grade Non-hodgkin's Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Alberta Health services
4. Oversight
5. Study Description
Brief Summary
Low grade lymphoma patients receive R-ICE reinduction therapy followed by allogeneic stem cell transplanation.
Detailed Description
Low grade lymphoma patients receive R-ICE reinduction therapy followed by allogeneic stem cell transplanation if they have an HLA matched sibling, or an autologous transplant if they do not.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Grade Lymphoma
Keywords
autologous and allogeneic stem cell transplantation, low grade lymphoma, mantle cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
stem cell source
Primary Outcome Measure Information:
Title
feasibility
Title
mortality
Title
overall survival
Title
event free survival
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
indolent histology lymphomas after relapse 1 or 2 LVEF > 50% Creatinine < 150 umol/L bilirubin < 30 umol/L wbc >3.5X10^9/L platelets >100X10^9/L other medical condition as controlled
Exclusion Criteria:
pregnant lactating HIV positive CNS involvement by lymphoma other malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doug Stewart
Organizational Affiliation
Alberta Cancer Board - TBCC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
21831743
Citation
Stewart DA, Duan Q, Carlson L, Russell JA, Bahlis NJ, Duggan P, Hasegawa W, Voralia M. A prospective phase II study of RICE re-induction, then high-dose fludarabine and busulfan, followed by autologous or allogeneic blood stem cell transplantation for indolent b-cell lymphoma. Clin Lymphoma Myeloma Leuk. 2011 Dec;11(6):475-82. doi: 10.1016/j.clml.2011.06.012. Epub 2011 Aug 10.
Results Reference
derived
Learn more about this trial
HDCT and Stem Cell Transplantation for Mantle Cell and Relapsed Low Grade Non-hodgkin's Lymphoma
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